legislation-obligation
legislation-obligation
Substance Regulatory Obligations
OBL
Bis(2-propylheptyl) phthalate
EC number: 258-469-4
CAS number: 53306-54-0
Last updated: 20/05/2024
ECHA Legislation Regulatory Obligations
Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.
Food Contact Recycled Plastic Materials and Articles Regulation-repealed
FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use
This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.
| Name | CAS | Physical form | FCM No | Ref No. | Additive or PPA | Use as monomer/macromolecule | FRF applicable | SML (mg/kg) | SML(T) Group Restriction No | SML(T) Group FCM substances | SML(T) (mg/kg) | Restriction(s) | Notes on verification | Notes | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 |
729 |
75105 |
yes |
no |
no |
G26 Group Restriction No. 26 corresponds to FCM substance No. 728,729. Group restriction specification is expressed as the sum of the substances. |
728,729 |
9 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
Details | ||||
|
phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 |
729 |
75105 |
yes |
no |
no |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815. Group restriction specification is expressed as the sum of the substances. |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815 |
60 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
Details | ||||
|
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 |
728 |
75100 |
yes |
no |
no |
G26 Group Restriction No. 26 corresponds to FCM substance No. 728,729. Group restriction specification is expressed as the sum of the substances. |
728,729 |
9 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
Details | ||||
|
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 |
728 |
75100 |
yes |
no |
no |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815. Group restriction specification is expressed as the sum of the substances. |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815 |
60 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
Details | ||||
Plastic Materials and Articles Regulation
FCM and Articles Regulation, Annex I - Authorised Substances
This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
| Name | CAS | FCM No | Ref No. | Additive or PPA | Use as monomer/macromolecule | FRF applicable | SML (mg/kg) | SML(T) Group Restriction No | SML(T) Group FCM substances | SML(T) (mg/kg) | Restriction(s) | Notes on verification | Notes | Physical form | Expressed As | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 |
729 |
75105 |
yes |
no |
no |
G26 Group Restriction No. 26 corresponds to FCM substance No. 728,729. Group restriction specification is expressed as the sum of the substances. |
728,729 |
1.8 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
As the sum of the substances |
Details | ||||
|
phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 |
729 |
75105 |
yes |
no |
no |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085. Group restriction specification is expressed as the sum of the substances (plasticisers). |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085 |
60 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
eupn3 Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085 |
As the sum of the substances |
Details | |||
|
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 |
728 |
75100 |
yes |
no |
no |
G26 Group Restriction No. 26 corresponds to FCM substance No. 728,729. Group restriction specification is expressed as the sum of the substances. |
728,729 |
1.8 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
eupn3 Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085 eupn4 Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). |
As the sum of the substances |
Details | |||
|
phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9 |
728 |
75100 |
yes |
no |
no |
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085. Group restriction specification is expressed as the sum of the substances (plasticisers). |
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815,1078,1085 |
60 mg/kg |
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae;(c)technical support agent in concentrations up to 0,1 % in the final product. Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
V7 If testing in food is performed, Annex V 1.4 shall be taken into account. |
eupn3 Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085 eupn4 Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). |
As the sum of the substances |
Details | |||
Recycled Plastic Food Contact Materials
Recycled Plastic FCMs - Regulation (EU) 2022/1616
The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.